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Trial Title:
Exploratory Study of Intermittent Hypoxia Intervention on Colorectal Cancer
NCT ID:
NCT06584318
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Hypoxia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Intermittent hypoxia intervention
Description:
The intermittent hypoxia protocol refers to 6 cycles of 10 minutes hypoxia inhaling
interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart)
in 7 days.
Arm group label:
patients
Summary:
This study aims to explore the safety and efficacy of intermittent hypoxia intervention
on patients with colorectal cancer.
Detailed description:
The hypoxic adaptive response is a form of acquired tolerance that occurs by activating
internal cellular protective mechanisms and enhancing immune function.This technology was
initially utilized in sports training and high-altitude medicine to enhance strength,
endurance, and overall athletic performance, as well as to enhance the body's adaptation
to high-altitude hypoxia. This technology was initially utilized in sports training and
high-altitude medicine to enhance strength, endurance, and overall athletic performance,
as well as to enhance the body's adaptation to high-altitude hypoxia.
Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with
brief exposure to hypoxia. Previous studies have found that short-term intermittent
hypoxia can increase the sensitivity of hypoxia and reduce the severity of acute hypoxia
injury, and alleviate acute hypoxia injury by reducing the inflammatory response caused
by hypoxia. Intermittent hypoxia has been shown in our team's work to effectively inhibit
colorectal cancer tumor progression in mice by enhancing immune cell function. This study
aims to explore the safety and efficacy of IH in patients with colorectal cancer using a
non-randomized self-controlled trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with colorectal cancer between ages of 18 and 65 years.
- Colorectal cancer stage Ⅰ,Ⅱ.
- Subjects or their legally authorized representative can provide informed consent.
Exclusion Criteria:
- History of cardiovascular, cerebrovascular, dermatological, and hematological
diseases.
- History of pulmonary, hepatic, kidney, dermatologic and hematologic diseases.
- History of pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and
neurological disorders.
- History of substance abuse.
- Participating in other drug or medical device studies.
- History of organ transplantation, including allogeneic stem cell and immune cell
transplantation.
- Recent severe infection within 4 weeks.
- Received cancer treatment, including chemotherapy and radiotherapy, within 4 weeks.
- Underwent major surgery within 28 days.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xuanwu Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xunming Ji, M.D.;Ph.D.
Start date:
March 1, 2024
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Capital Medical University
Agency class:
Other
Source:
Capital Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06584318
